Shots - Health Blog

7:33 pm

Thu October 11, 2012

Meningitis Outbreak Puts Doctors, Regulators In New Territory

There's new information on the ongoing outbreak of a rare meningitis caused by a fungus that somehow got into a steroid drug. Federal officials now say the drug got injected into 14,000 patients — 1,000 more than earlier thought.

All but one of the 169 cases reported thus far were caused by a fungus called Exserohilum that is almost unheard of as a cause of meningitis. One non-meningitis infection in a Michigan patient occurred after the tainted drug was injected into an ankle. Fourteen patients have died so far.

Little is known about how to diagnose and treat this kind of fungal meningitis. It can be slow-growing, so officials from the Centers for Disease Control and Prevention, who previously said the incubation period was a month, are now saying that patients and doctors need to be vigilant for headache, fever and other symptoms for "at least several months following injection."

Moreover, diagnostic tests are unreliable.

"Patients and doctors should not assume that a negative test means there is no infection," the CDC's Todd Weber said on a Thursday conference call. "Patients may be diagnosed with meningitis, but fungal testing may be negative."

Such patients should be treated with powerful anti-fungal drugs anyway, Weber says.

"This is new territory for public health and the clinical community," he says.

A Regulatory Issue

Meanwhile, there were new developments in the investigation into how the drug contamination occurred. It's shaping up to be a spectacular failure of consumer protection.

For instance, Massachusetts officials say the New England Compounding Center, which shipped nearly 18,000 doses of the suspect drug, called methylprednisolone acetate, misled them about its operations. Thus, they didn't realize the company was operating on such a large scale.

"The regulatory authority of the Massachusetts Board of Pharmacy does not include tracking volumes of medicines," says Dr. Madeleine Biondolillo of the Massachusetts Department of Public Health.

Likewise, she says, state officials did not realize until this outbreak that the New England Compounding Center was not following the pharmacy board's requirement that compounding pharmacies dispense drugs only upon receipt of a patient-specific prescription. That is, it's not supposed to ship large quantities of drugs to hospitals, clinics and doctors' offices for administration to anonymous patients.

"It looks, through the investigation, as though they have violated that aspect of the state licensing regulations despite their assertions they were operating under the regulations," Biondolillo says.

Lax oversight of compounding pharmacies — a type of drug supplier few Americans have heard of — is not a problem that popped up overnight.

It's a trend that reaches back more than a decade as some compounding pharmacies have gone national. Out of an estimated 3,000 compounding pharmacies in the nation, one pharmacy expert estimates, the number of industrial-scale firms that ship nationally "is in the tens, not the hundreds."

Originally every corner drugstore was a compounding pharmacy, custom-mixing prescriptions patient by patient. Federal and state laws still pretend that's what all compounding pharmacies are.

But Deborah Autor, a deputy commissioner at the Food and Drug Administration, acknowledges that regulatory authority is out-of-date.

"The world has changed a lot since the days of the mortar and pestle," Autor said during the Thursday briefing. "And this is the time for pharmacists, for lawmakers, for regulators, for doctors, to sit down and grapple with this new model and come up with a regulatory scheme that appropriately controls the risk."

Autor clearly believes the FDA needs more authority. Some say the FDA could have done more with the authority it has.

For decades the agency has been aware that compounding pharmacies were morphing into mini-drug companies. And it's been aware that many patients have been injured and killed by their products.

Greed An Underlying Factor?

"Unfortunately, we've been here before," Erin Fox of the University of Utah's Drug Information Service told Shots. "There have been a number of bad patient outcomes related to compounded drugs."

Back then, the FDA got Congress to pass a law giving it more authority over compounding pharmacies. But in 2002, the U.S. Supreme Court struck down its no-advertising provisions on First Amendment grounds, and the rest of the statute fell, too.

"After that, the FDA really had the wind knocked out of its sails, in terms of trying to regulate these types of pharmacies," says Kevin Outterson, a Boston University law professor.

So, regulation has largely been left up to 50 state boards of pharmacy.

Jay Campbell, director of the North Carolina board, says a mistake at an industrial-size compounding pharmacy poses a much bigger problem than one at a corner drugstore.

The corner drugstore patient may be harmed, he says, "but there's very little risk of that sort of harm being spread among hundreds or even thousands of patients."

Campbell says the growth of large compounding pharmacies is simply a product of market opportunity and permissive regulation.

"You can't help but look at the scope of some of the things that have been going on and the risk undertaken and not be concerned that greed is an underlying factor here," he says.

Copyright 2013 NPR. To see more, visit http://www.npr.org/.

Transcript

ROBERT SIEGEL, HOST:

From NPR News, this is ALL THINGS CONSIDERED. I'm Robert Siegel.

The number of people injured by contaminated steroid injections continues to climb. As of today, 170 patients in 11 states have gotten a rare and dangerous form of meningitis, and 14 have died. Meanwhile, the focus is turning to how such a thing could have happened. The question comes down to a kind of drug supplier few Americans have heard of. They're called compounding pharmacies.

NPR's Richard Knox has been looking into what these pharmacies do and who's supposed to make sure they're safe.

RICHARD KNOX, BYLINE: One thing seems clear: This outbreak of drug-related meningitis represents a spectacular failure of consumer protection. But it's not a problem that popped up overnight. It's a trend over the past decade or more as some compounding pharmacies have gone national. Some of them, like the New England Compounding Center that shipped nearly 18,000 doses of the tainted drug to 23 states, are a long way from their roots.

Originally, every corner drugstore was a compounding pharmacy, custom-mixing prescriptions patient by patient. Federal and state law still pretend that's what all compounding pharmacies are.

KEVIN OUTTERSON: Current rules with the FDA and the states don't clearly distinguish between the corner pharmacy, you know, from 100 years ago and what's happening now in this industrial-scale national compounding.

KNOX: That's Kevin Outterson. He's a Boston University law professor who studied the trend.

OUTTERSON: The idea that the pharmacist has a direct relationship with the patient is very attenuated today. You don't see that at all with mail-order pharmacies. You certainly don't see it with these type of compounding pharmacies. But even when you go to the corner CVS or Walgreens, we rarely sit down and speak with the pharmacist.

KNOX: For decades, the FDA has been aware that compounding pharmacies were morphing into mini-drug companies. And it's been aware that many patients have been injured and killed by their products. Just last year, contaminated nutritional supplements from an Alabama company killed nine patients and injured 10 others.

But pharmacy experts say such episodes stretch back to the 1990s. Back then, the FDA got Congress to pass a law giving it more authority over compounding pharmacies. But in 2002, the U.S. Supreme Court struck down its no-advertising provisions on First Amendment grounds, and the rest of the statute fell too.

OUTTERSON: After that, the FDA really had the wind knocked out of its sails in terms of trying to regulate these types of pharmacies.

KNOX: So regulation has largely been left to 50 state boards of pharmacy. Jay Campbell is director of the pharmacy board in North Carolina where some of the contaminated steroid drug ended up. He says a mistake at an industrial-size compounding pharmacy poses a much bigger problem than one at the corner drugstore.

JAY CAMPBELL: True that patient may be harmed, and that is a problem in and of itself, but there's very little risk of that sort of harm being spread among hundreds or even thousands of patients.

KNOX: Campbell says the growth of large compounding pharmacies is simply a product of market opportunity and permissive regulation.

CAMPBELL: You can't help but look at the scope of some of the things that have been going and the risks undertaken and not be concerned that greed is an underlying factor here.

KNOX: Massachusetts officials say they were misled by the company that caused the current problem that they didn't realize it was operating on such a scale. But others note that the company advertised openly. And one of the company's executives has served for years on the Massachusetts Board of Pharmacy.

Few doubt this episode will spark a lot of debate about what went wrong and how to fix it. Again, here's law professor Kevin Outterson.

OUTTERSON: I expect there'll be finger-pointing in many directions in the days to come.

KNOX: Some say the FDA could have done more with the authority it has. Others say the agency needs more. On a telephone briefing this afternoon, Deborah Autor of the FDA said the outbreak illustrates something needs to be done to clarify how compounding pharmacies are regulated.

DEBORAH AUTOR: The world has changed a lot since the days of mortar and pestle. And this is the time for pharmacists, for lawmakers, for regulators, for doctors to sit down and grapple with this new model and come up with a regulatory scheme that appropriately controls the risk.

KNOX: Already, two members of Congress have said they're writing bills to try to prevent more patients from being harmed by compounding pharmacies in the future.